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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063142
Company: HQ SPECLT PHARMA

Products on ANDA 063142

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063142

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/1993	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
02/21/2018	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
02/21/2018	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/12/2017	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/28/2013	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/23/2007	SUPPL-6	Labeling		Label is not available on this site.
02/28/2007	SUPPL-4	Labeling		Label is not available on this site.
11/05/1993	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/14/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 063142

AMPICILLIN SODIUM

INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090889	ACS DOBFAR SPA
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065493	EUGIA PHARMA SPECLTS
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	063142	HQ SPECLT PHARMA
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201404	ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202198	ONESOURCE SPECIALTY
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090581	SAGENT PHARMS INC
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	061395	SANDOZ

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